SMOOV O10

K192016 · Alber GmbH · ITI · May 19, 2020 · Physical Medicine

Device Facts

• Record ID: K192016
• Device Name: SMOOV O10
• Applicant: Alber GmbH
• Product Code: ITI · Physical Medicine
• Decision Date: May 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SMOOV O10 is a medical device for active wheelchair users with a user weight of 140 kgs and who are reliant on a wheelchair as a result of their disability. The smoov is an add-on drive for wheelchairs that is attached to a manual wheelchair, converting it into an electrically driven wheelchair and thus signific- antly increasing the wheelchair user's mobility and flexibility. The smoov must always be used, transported, maintained and serviced as described in this operating manual. The smoov must only be attached to and operated with wheelchairs that are listed in Alber's mounting database. The selection is made by the specialist dealer or by Alber itself.

Device Story

SMOOV O10 is an add-on power drive for manual wheelchairs; attaches to rigid frames via bracket or foldable frames via adapter. System comprises a drive unit (brushless motor, lithium-ion battery, locking claw) and a wireless control unit (speed setting knob, display). User operates control unit to toggle power and adjust speed via turnwheel. Smartphone app provides additional functionality (cockpit, GPS tour computer, driving modes, firmware updates). Device intended for active users to increase mobility/flexibility; reduces pushing effort. Used in outdoor environments (solid pavement). Safety features include emergency stop, encrypted wireless communication, and automatic motor cutoff upon system fault. Benefits include extended range and reduced physical strain for wheelchair users.

Clinical Evidence

Bench testing only. Performance verified against ISO 7176 series (stability, brakes, energy consumption, dimensions, speed/acceleration, obstacle climbing, climatic tests, power/control systems, EMC). Cybersecurity evaluated for SweynTooth vulnerabilities; wireless communication encrypted and firmware patched.

Technological Characteristics

Add-on drive unit with 250W brushless motor, 36V Li-ion battery. Control unit with 3.6V Li-ion battery. Wireless interface: IEEE 802.15.4 (BLE). Materials: Aluminum fork, rubber tire. Protection rating: IPX4. Standards: ISO 7176 series (1-6, 8-11, 13-15, 21), ISO 10993-1/5/10, IEC 60335-2-29, IEC 62133, UN 38.3, ANSI C63.27-2017.

Indications for Use

Indicated for active wheelchair users (up to 140 kg) who are physically and mentally capable of safely controlling a manual wheelchair in typical situations, including inclines. Provides auxiliary power to manual wheelchairs to reduce pushing effort.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• SmartDrive (MX2+) (K151199)

Submission Summary (Full Text)

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May 19, 2020

Alber GmbH Michael Vent Official Correspondent for Alber GmbH Vor dem Weißen Stein 21 Albstadt, 72461 DE

# Re: K192016

Trade/Device Name: SMOOV 010 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 14, 2020 Received: February 19, 2020

Dear Michael Vent:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Heather Dean, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192016

Device Name SMOOV 010

#### Indications for Use (Describe)

The SMOOV O10 add-on drive for wheelchairs is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users. It is designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.

Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

Image /page/3/Picture/2 description: The image shows a logo with the word "alber" in lowercase letters. The background is a solid purple color. The word "alber" is written in a sans-serif font, and the letters are white. The logo is simple and modern.

| Applicant: | Alber GmbH<br>Vor dem Weißen Stein 21<br>72461 Albstadt, Germany<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr Michael Vent<br>Phone: [phone]<br>Email: [e-mail] |
| Device: | Proprietary: SMOOV O10<br>Common Name: add-on drive for wheelchairs<br>Classification Name: Powered wheelchair<br>Device Class: II, 21 CFR 890.3860<br>Classification Panel: Physical Medicine<br>Product Code: ITI |
| Prepared Date: | 18th May, 2020 |

#### Predicate Device Information:

We claim substantial equivalence for the subject device SMOOV O10 in intended use, design and function to the predicate device SmartDrive (MX2+) (K151199) by MaxMobility GmbH.

#### Indications for Use:

The SMOOV O10 add-on drive for wheelchairs is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users.

It is designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.

#### Intended Use:

The SMOOV O10 is a medical device for active wheelchair users with a user weight of 140 kgs and who are reliant on a wheelchair as a result of their disability. The smoov is an add-on drive for wheelchairs that is attached to a manual wheelchair, converting it into an electrically driven wheelchair and thus signific- antly increasing the wheelchair user's mobility and flexibility. The smoov must always be used, transported, maintained and serviced as described in this operating manual. The smoov must only be attached to and operated with wheelchairs that are listed in Alber's mounting database. The selection is made by the specialist dealer or by Alber itself.

#### Device Description:

The SMOOV O10 drive unit is attached and detached to rigid wheelchairs via a bracket or alternatively to a foldable wheelchair with an optional adapter. The SMOOV 010 converts the user´s manual wheelchair, when needed, in a partly motorized wheelchair to extend the mobility and flexibility of the wheelchair user. To extend functionality an optional Smartphone App is available.

The user interacts with the SMOOV 010 via control unit mounted to the wheelchair for wireless interfacing with the drive unit. The control unit is used to switch on and off the power assistance and adjust the speed of the drive unit via the turnwheel.

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The main parts of the drive unit are as follows:

- . Rotating drive wheel consisting of a brushless motor with tyre and aluminium fork
- Control Electronic for the motor and wireless interface for communication with control unit ● and optional smartphone App
- Integrated lithium ion battery pack with battery management system
- . On/Off button and remaining capacity and operating mode indicator
- Carrying and release handle
- Magnetic charger socket for the integrated battery (Easy Connect) for connecting the battery ● charger
- USB-C socket to charge the control unit or a smartphone
- Position light
- Locking claw for attaching and detaching the drive unit to the bracket ●

The main parts of the control unit are as follows:

- Wireless interface for communicating with the drive unit
- On/Off button and speed setting knob
- Integrated Li-ION battery cell including battery management system
- USB-C socket for charging via drive unit or other external USB-C charger ●
- Display for operating status and remaining capacity of drive unit and control unit ●

To charge the battery of the drive unit a battery charger is available. Main attributes:

- Multi-range charger 100-240 VAC, 50-60 Hz ●
- . Automatic charging and switch-off mechanism
- . Indicating status and mains

## Drive Unit

| Range: | up to 20 km as per ISO 7176 - 4 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Nominal gradient: | 16% [9°] - also note the limit values specified by the<br>wheelchair manufacturer. |
| Maximum downhill grade: | Depends on the user and weight of the wheelchair. Also note<br>the limit values specified by the wheelchair manufacturer |
| Cornering radius (minimum): | Double the width of the wheelchair (if using the smoov) |
| Maximum speed: | Standard: 6 km/h Optional: 10 km/h |

250 W

36 VDC

170 kg

IPX4

-25° C to +50° C

-40° C to +65° C

max. 140 kg

Rated power of engine: Operating voltage: Operating temperature: Storage temperature: Weight of person: Max. permissible overall weight: Protection rating:

# Battery pack

Cell type: Rated operating capacity: Rated capacity:

Lithium-ion 18650 36 V 6.2 Ah

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Image /page/5/Picture/0 description: The image shows the word "alber" in white font on a purple background. The word is written in lowercase letters and appears to be a logo. The font is rounded and sans-serif, giving it a modern and clean look. The purple background is a solid color, providing a strong contrast to the white text.

| Rated energy: | 224 Wh |
|------------------------|---------------------------|
| Charging temperature: | 0° C to +45° C |
| Operating temperature: | -25° C to +50° C |
| Protection rating: | IPX4 |
| Control unit | |
| Cell type: | Lithium-ion 18650 |
| Rated voltage: | 3.6 VDC |
| Rated capacity: | 2.6 Ah |
| Rated energy: | 9.36 Wh |
| Charging temperature: | 0° C to +45° C |
| Operating temperature: | -25° C to +50° C |
| Charger | |
| Model: | Smoov Charger |
| Mains voltage: | 100...240 VAC, 50...60 Hz |
| Power output: | 48 W |
| Output voltage: | 48 VDC |
| Output current: | 1.0 A |
| Protection rating: | IP X4 |
| Ambient temperature: | Operation 0...40 °C |
| Storage | -40...+65 °C |
| Humidity: | Operation 10...80% |
| Storage | 5...95% |
| Air pressure: | Operation 500 1060 hPa |

#### Weight of components

Storage

Drive unit (including battery): Control unit (including battery): Battery charger: Total weight:

7.2 kg 0.25 kg 0.5 kg 7.95 kg (may differ depending on version or accessories)

700...1060 hPa

#### Radio Frequency Wireless Technology Drive Unit

Type of wireless technology FCC compliance: FCC ID: Wireless Coexistence Compliance: EMC Compliance RF frequency range: RF maximum output power: Wireless operating range: Wireless functions:

## Control Unit

Type of wireless technology: FCC compliance: FCC ID:

EEE 802.15.4 (Bluetooth Low Energy) CFR47, Part 15 A8TBM78ABCDEFGH ANSI C63.27-2017, separation distance ≥0.25m ISO 7176-21:2009 2.402 GHz to 2.480 GHz 1.5dBm 10m / class 2 Speed, Emergency stop, Operating mode (on/standby)

IEEE 802.15.4 (Bluetooth Low Energy) CFR47, Part 15 ZAT26M1

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Image /page/6/Picture/0 description: The image is a square with a purple background. The word "alber" is written in white, sans-serif font in the lower center of the square. A small circle with a registered trademark symbol is in the upper right corner of the square.

Wireless Coexistence Compliance: ANSI C63.27-2017, separation distance ≥0.25m EMC Compliance: ISO 7176-21:2009 Wireless RF frequency range: 2.402 GHz to 2.480 GHz Wireless RF maximum output power: 5dBm Wireless operating range: 10m / class 2 Wireless functions: Speed, Emergency stop, Operating mode (on/standby)

## Cybersecurity assessment/mitigation, including SweynTooth vulnerabilities evaluation

Sweyn Tooth affects the wireless communication technology known as Bluetooth Low Energy (BLE). BLE allows two devices to "pair" and exchange information to perform their intended functions while preserving battery life. The technology can be found in medical devices as well as other devices, such as consumer wearables. SweynTooth may allow an unauthorized user to wirelessly crash the device (crash), stop it from working (deadlock), or access device functions normally only available to the authorized user (bypass security).

These vulnerabilities cannot be exploited remotely and all of these attacks require that the device Bluetooth is enabled and that the attacker is within close physical proximity (i.e., within Bluetooth range) of the device.

Our preventive actions to avoid harm: All wireless communication is encrypted. The chipsetmanufacturers have issued patches to avoid external attacks. We have performed firmware updates on affected devices. These patches, made to address the vulnerabilities, don't affect device safety or effectiveness.

In the unlikely event a successful attack, the SMOOV O10 motor stops and the driving support stops in order to enter the safe state of the system (=no more auxiliary power provision). Unintended movements are impossible.

| | SUBJECT DEVICE<br>SMOOV O10<br>(K192016) | PREDICATE DEVICE<br>Smartdrive MX2<br>(K151199) |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication For Use | The SMOOV O10 add-on drive for<br>wheelchairs is intended to provide<br>auxiliary power to manual wheelchairs<br>to reduce the pushing power needed by<br>their users.<br>It is designed to provide support to<br>active wheelchair users who are<br>physically and mentally able to safely<br>control a manual wheelchair in typical<br>situations, including inclines, even<br>manually. | The SmartDrive MX2 Wheelchair<br>Power Assist is intended to provide<br>auxiliary power to manual wheelchairs<br>to reduce the pushing power needed by<br>their users, including pediatrics. It is<br>intended to be used by users capable of<br>operating and maneuvering a powered<br>and manual wheelchair. |
| Intended Use | The SMOOV O10 is a medical device<br>for active wheelchair users with a user<br>weight of 140 kgs and who are reliant<br>on a wheelchair as a result of their<br>disability. The smoov is an add-on<br>drive for wheelchairs that is attached to<br>a manual wheelchair, converting it into<br>an electrically driven wheelchair and<br>thus signific- antly increasing the<br>wheelchair user's mobility and<br>flexibility. | The Max Mobility SmartDrive<br>Wheelchair Power Assist device is<br>exclusively intended to provide<br>auxiliary power to manual wheelchairs<br>to reduce the pushing power needed by<br>their users, including pediatrics, with a<br>user weight of 30 to 331 lbs (14 - 150<br>kgs). It is intended to be used by users<br>capable of operating and maneuvering a<br>powered and manual wheelchair, |
| | | |
| | The SMOOV O10 must always be<br>used, transported, maintained and<br>serviced carefully to keep its<br>performance, efficiency and safety.<br>The SMOOV O10 must only be<br>attached to and operated with<br>wheelchairs that are listed in Alber's<br>mounting database.<br>The selection is made by the specialist<br>dealer or by Alber itself. | ultimately empowering them through<br>enhanced mobility. |
| Permissible conditions of<br>use/locations of operation<br>Type Environment of Use | Observe the permissible conditions<br>of use of the wheelchair to which<br>the smoov is attached. In addition to observing the<br>information provided about the<br>smoov, it is also imperative to<br>observe the information provided<br>by the wheelchair manufacturer<br>(e.g. maximum gradeability,<br>maximum permissible height of<br>obstacles, maximum user weight,<br>maximum speed, etc.). The lowest<br>values always apply. Any limits regarding the operation<br>of your wheelchair (e.g. maximum<br>gradeability, maximum permissible<br>height of obstacles, maximum user<br>weight etc.) must also be observed<br>when using the smoov. The SMOOV O10 must only be<br>operated at temperatures between -<br>25 °C and +50 °C. Therefore, do<br>not expose the smoov to any heat<br>sources (such as intense sunlight) as<br>this may cause surfaces to reach<br>high temperatures. The SMOOV O10 is designed for<br>light outdoor use (e.g. solid<br>pavement), avoid using the<br>wheelchair on soft ground (e.g.<br>loose chipping, sand, mud, snow,<br>ice or deep puddles). | Do not operate over significantly<br>rough terrain, very slick surfaces,<br>extreme slopes, or loose ground. This<br>may cause a loss of traction, leading<br>to injury or damage to your<br>SmartDrive and void the warranty. The SmartDrive is not designed to<br>drive up or down large curbs/steps.<br>Only perform this maneuver when<br>absolutely necessary and always ask<br>for help. Also, be sure to turn off<br>your SmartDrive wristband. Use extreme caution when operating<br>a SmartDrive at- tached wheelchair<br>when near streets. Consider<br>powering off the wristband to reduce<br>the chance of accident or injury. When crossing major roads,<br>intersection, railway crossings or<br>highways as well as when you drive<br>steep, long slopes you should always<br>consider having somebody<br>accompany you in the interest of<br>your safety. With regards to driving up and down<br>slopes, please adhere to the<br>instructions and specifications given<br>by the diverse wheelchair<br>manufacturers. Riding over curbs or obstacles can<br>cause tipping and serious bodily<br>harm. Turn off your SmartDrive<br>wristband when attempting to ride in<br>these situations. If you have any<br>doubt that you can safely cross any<br>curb or obstacle, ALWAYS ask for<br>help. Be aware of your riding skills<br>and personal limitations. Develop<br>new skills only with the help of a<br>companion. |
| Market Segment | Active | Active |
| Introduced to the market | spring 2019 | 2012 Smartdrive<br>2015 MX2<br>MX2+ |
| Wheelchair Compatibility | Rigid W/C frames: Universal brackets on the axle tube Folding frames: adapter axle required | Rigid W/C frames: Universal bracket on the axle tube For folding W/C adapter axle required. This axle is firmly connected to the drive unit. |
| Available Wheelchair Wheel-Diameters (inch) | 22" - 26" | 22" - 26" |
| Device Wheel Dimensions (inch) | Diameter: 6.4"<br>Width: 3,9" | Diameter: 7.6"<br>Width: 2.8" |
| Max. user weight (kg) | 140 | 150 |
| System weight (kg) | 7,2 | 6 |
| Nominal Power (Watt) | 250 | 250 |
| Max. assisted Speed (km/h) | 6<br>10 | 6<br>8,9 |
| Nominal Range (km) | 20 | 19,8 |
| Assist Levels | Speed adjustments stepless via<br>clickwheel | Keeps the speed by knocking on the<br>wristband |
| Control Unit | Bluetooth clickwheel attached to W/C | Bluetooth wristband |
| Adjustment of drive<br>parameters | acceleration and speed depending on<br>the angle of the drive wheel, 4<br>programmable driving modes. STOP<br>pushbutton | Acceleration and stop by tapping the<br>wristband. |
| Smartphone App for end user | Android and iOS<br>Free features:<br>Cockpit, battery capacity, range, tour<br>computer via GPS, 4 programmable<br>driving modes, On/Off rear light,<br>worldwide service contact details,<br>firmware updates over the air, failure<br>and warnings<br>chargeable: Navigation | Android and iOS<br>Primariliy statistical purpose (counting<br>daily pushes, distance etc.), firmware<br>updates over the air. |

## Comparison to the Predicate Device

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Image /page/7/Picture/1 description: The image shows a purple square with the word "alber" in white, lowercase letters. The letters are stylized with rounded edges. In the upper right corner of the square, there is a small, circular logo that is partially obscured.

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Image /page/8/Picture/0 description: The image shows the word "alber" in white font against a purple background. The word is written in lowercase letters and appears to be part of a logo or brand name. The purple background is a solid color, providing a strong contrast to the white text.

Both, predicate device SmartDrive MX2 and the subject device SMOOV 010 are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.

Both devices are provided as accessory to standard manual wheelchairs in order to provide assistive power for the user. Both devices are similar in their technological characteristics including their wireless controllercomponents. It was also demonstrated that their technological characteristics are equivalent.

Both devices are meant for Over-the-counter sale and do not require any set-up or training besides the instructions on the labeling.

Even the wording to describe the indications for use and the intended use slightly differ, both devices are considered substantially equivalent concerning these aspects.

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Image /page/9/Picture/0 description: The image features a square logo with a purple background. The word "alber" is written in white, lowercase letters across the center of the square. The font is sans-serif, and the letters are slightly rounded. In the upper right corner of the square, there is a small, circular symbol, possibly a registered trademark symbol.

## The subject device is in conformity with the technical and performance requirements of the following FDA recognized Standards and Guidance Documents:

| Standard | Name | Recognition# |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| ISO 10993-1:2009 | Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk<br>Management Process | 2-220 |
| ISO 10993-5:2009 | Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | 2-245 |
| ISO 10993-10:2010 | Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | 2-174 |
| IEC 60335-2-29:2016 | Safety of household and similar electrical appliances Part 2-29: Particular requirements for<br>battery chargers | - |
| IEC 62133:2012 | Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety<br>Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For<br>Use In Portable Applications [Including: Corrigendum 1 (2013)] | 19-13 |
| UN 38.3 | Recommendations of the TRANSPORT OF DANGEROUS GOODS, Manual of Test and<br>Criteria, Part III, Lithium metal and lithium ion batteries | - |
| ISO 7176-1: 2014 | Wheelchairs - Part 1: Determination Of Static Stability | 16-195 |
| ISO 7176-2: 2017 | Wheelchairs - Part 2:Determination Of Dynamic Stability Of Electrically Powered Wheelchairs | 16-202 |
| ISO 7176-3: 2012 | Wheelchairs - Part 3: Determination Of Effectiveness Of Brakes | 16-192 |
| ISO 7176-4: 2008 | Wheelchairs - Part 4: Energy Consumption Of Electric Wheelchairs And Scooters For<br>Determination Of Theoretical Distance Range | 16-162 |
| ISO 7176-5: 2008 | Wheelchairs - Part 5: Determination Of Overall Dimensions, Mass And Manoeuvring Space | 16-163 |
| ISO 7176-6: 2018 | Wheelchairs - Part 6: Determination Of Maximum Speed, Acceleration And Deceleration Of<br>Electric Wheelchairs | 16-204 |
| ISO 7176-8: 2014 | Wheelchairs - Part 8: Requirements And Test Methods For Static, Impact And Fatigue Strengths | 16-197 |
| ISO 7176-9: 2009 | Wheelchairs - Part 9: Climatic Tests For Electric Wheelchairs | 16-167 |
| ISO 7176-10: 2008…